MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY SELF CONTAINED BIOLOGICAL INDICATOR

Lot Number 150922

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/28/2015

Event Type  No Answer Provided  

Event Description

The user facility reported a failed bi result.Not all instruments were recalled after the reported event.It is unknown if instruments were used on the patient or not.The user facility followed their protocol for notifying patients.

Manufacturer Narrative

Verify biological eo test pack's instructions for use states, "if the scbi starts to demonstrate turbidity or a color change from blue to yellow, conditions for sterility were not achieved.Follow departmental procedures for reporting sterility failures." the amsco eagle series 3017 was confirmed to be operating according to specification; the cycle tape evidenced passing results.The two positive bis and one unprocessed test pack were returned to steris for evaluation.Steris quality evaluated the processed bis and noted the vials were broken.The damage observed is indicative of improper use of the bi activator.The unprocessed test pack was processed by steris, incubated, and showed no sign of growth.Steris performed retain testing on the lot subject of the reported event and all samples showed no growth.Steris performed in-service training on the proper use and handling of the indicator.

• Brand Name: VERIFY SELF CONTAINED BIOLOGICAL INDICATOR
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr; mentor OH 44060
• Manufacturer (Section G): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr.; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4546364
• MDR Text Key: 5526505
• Report Number: 3004080920-2015-00007
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 150922
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other